All things QA
Rules and Regulations
It's All Linear
Miscellaneous
Testing FACTS
100
Manages the laboratory's policies, procedures and documentation.
What is document control?
100
Set of written instructions that describes, in detail, how to perform a laboratory process or experiment safely and effectively.
What is SOP?
100
The maximum range of values that can be assayed accurately without dilution
What is AMR?
100
Parallel testing of new reagent and shipments with current lot numbers
What is lot to lot assessment?
100
Interval between specimen receipt by laboratory personnel and results reporting
What is Turn Around Time?
200
Identification and evaluation of potential errors for the test system throughout all phases of testing.
What is Risk Assessment?
200
Samples that are tested with the routine patient workload by regularly scheduled personnel
What are PT tests?
200
The ability to recover the correct amount of analyte present in the specimen
What is Accuracy?
200
Activities that prolong the life of an instrument or minimize breakdowns or mechanical malfunctions.
What is preventative maintenance?
200
Quality control results that either decrease or increase consistently over a period of 5 to 7 days.
What is a trend?
300
Uploaded documents pertaining to upcoming CAP inspection can be found under this tab.
What is Inspection Proof?
300
Regulates labs testing human specimens and ensures they provide accurate, reliable, and timely patient test results no matter where the test is done.
What is CLIA?
300
The ability to obtain the same result upon repeated measurement of a specimen
What is Precision?
300
The determination of a lab's testing performance for analytes when a commercial PT program is not readily available
What is alternative assessments?
300
Testing materials of known concentration in the same manner as patient specimens to assure the test system is accurately measuring samples.
What is calibration?
400
A systematic process for identifying the causal factors that underlie errors
What is Root Cause Analysis?
400
A set of policies, processes, procedures, and resources designed to ensure high quality in an organization's services
What is Quality Management System (QMS)?
400
The maximum amount of error(imprecision and bias combined)that is allowed for an assay
What is TEa?
400
Any released results associated with nonconforming laboratory services are identified and recalled
What is CAR?
400
Calculating the average value from a set of patient results and further using that value for control purposes
What are Patient Moving Averages?
500
Action taken to eliminate the cause of a potential nonconformity or error
What is preventative action?
500
System used to input, store and retrieve data in relation to activities performed in pre analytic, analytic and post phase of testing
What is LIS?
500
Verifies whether a method is properly calibrated by verifying both accuracy and reportable range; used for assays with less than a 3 point calibration.
What is Calibration Verification?
500
The determination of the ability of a test to diagnose or predict risk of a particular health condition or predisposition, measured by sensitivity, specificity, and predictive values
What is Clinical Validation?
500
Rating given by the FDA to commercially marketed in vitro diagnostic tests based on their risks to public health. Tests in this category are seen to have the highest risks to public health.
What is high complexity testing?